Dagenais Frédéric, Neville Catriona, Desmet Liesbet, Martineau Sarah
Faculté de Médecine, Université Laval, Québec, QC, Canada.
Queen Victoria Hospital NHS Foundation Trust, East Grinstead, West Sussex, United Kingdom.
JMIR Res Protoc. 2023 Jul 7;12:e47709. doi: 10.2196/47709.
Facial neuromuscular retraining (fNMR) is a noninvasive physical therapy widely used to treat peripheral facial palsies. It consists of different intervention methods that aim to reduce the debilitating sequelae of the disease. Recently, the use of mirror therapy in the acute facial palsy and postsurgical rehabilitation contexts has shown promising results, suggesting its use as an adjunct to fNMR in treating patients with later stages of paralysis, such as the paretic, early, or chronic synkinetic.
The main aim of this study is to compare the efficacy of an added mirror therapy component with fNMR in patients with peripheral facial palsy (PFP) sequelae in 3 different stages. The specific objectives of this study are to measure the effects of combined therapy compared to fNMR alone on (1) participants' facial symmetry and synkinesis, (2) quality of life and psychological aspects of the participants, (3) motivation and treatment adherence, and (4) different stages of facial palsies.
This study is a randomized controlled trial that compares the effect of fNMR combined with mirror therapy (experimental group: n=45) with fNMR alone (control group: n=45) in 90 patients with peripheral facial palsy presenting with sequelae 3-12 months after onset. Both groups will receive 6 months of rehabilitation training. Facial symmetry and synkinesis; participants' quality of life; and their psychological factors, motivation, and compliance will be assessed at baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3) postintervention. Outcome measures are (1) changes in facial symmetry and synkinesis assessed with facial grading tools, (2) quality of life changes with patient questionnaires, and (3) therapy motivation with a standardized scale, as well as adherence to treatment with metadata. Changes in facial symmetry and synkinesis will be judged by 3 assessors blinded to group assignment. Mixed models and Kruskal-Wallis, chi-square, and multilevel analyses will be conducted according to the appropriate variable type.
Inclusion will start in 2024 and is anticipated to be completed in 2027. The 12-month follow-up will be completed with the last patient in 2028. We expect patients included in this study to experience improvement in facial symmetry, synkinesis, and quality of life, regardless of group assignments. A potential benefit of mirror therapy for facial symmetry and synkinesis could be noted for patients in the paretic phase. We hypothesize better motivation and adherence to treatment for the mirror therapy group.
The results of this trial may provide new guidelines for PFP rehabilitation with patients dealing with long-term sequelae. It also fills the need for robust evidence-based data in behavioral facial rehabilitation.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/47709.
面部神经肌肉再训练（fNMR）是一种广泛用于治疗周围性面瘫的非侵入性物理疗法。它由不同的干预方法组成，旨在减少该疾病使人衰弱的后遗症。最近，在急性面瘫和术后康复背景下使用镜像疗法已显示出有前景的结果，这表明其可作为fNMR的辅助手段，用于治疗瘫痪后期的患者，如麻痹期、早期或慢性联动期患者。
本研究的主要目的是比较在3个不同阶段的周围性面瘫（PFP）后遗症患者中，添加镜像疗法成分的fNMR与单纯fNMR的疗效。本研究的具体目标是测量联合治疗与单纯fNMR相比，对（1）参与者面部对称性和联动症、（2）参与者的生活质量和心理方面、（3）动机和治疗依从性以及（4）面瘫不同阶段的影响。
本研究是一项随机对照试验，比较fNMR联合镜像疗法（实验组：n = 45）与单纯fNMR（对照组：n = 45）对90例周围性面瘫后遗症患者的效果，这些患者在发病后3 - 12个月出现后遗症。两组患者都将接受6个月的康复训练。将在干预前基线（T0）、干预后3个月（T1）、6个月（T2）和12个月（T3）评估面部对称性和联动症、参与者的生活质量以及他们的心理因素、动机和依从性。结局指标包括：（1）使用面部分级工具评估面部对称性和联动症的变化；（2）通过患者问卷评估生活质量的变化；（3）使用标准化量表评估治疗动机，以及通过元数据评估治疗依从性。面部对称性和联动症的变化将由3名对分组情况不知情的评估者进行判断。将根据适当的变量类型进行混合模型以及Kruskal - Wallis检验、卡方检验和多水平分析。
纳入工作将于2024年开始，预计在202�年完成。12个月的随访将在2028年最后一名患者完成。我们预计本研究纳入的患者，无论分组如何，面部对称性、联动症和生活质量都会有所改善。对于处于麻痹期的患者，可能会注意到镜像疗法在改善面部对称性和联动症方面的潜在益处。我们假设镜像疗法组的治疗动机和依从性更好。
本试验的结果可能为患有长期后遗症的PFP患者的康复提供新的指导方针。它也满足了行为面部康复中基于有力证据的数据的需求。
国际注册报告标识符（IRRID）：PRR1 - 10.219⁶/47709。
